Yes. With experience in more than 70 countries, we can help you meet all the logistical, cultural, and regulatory challenges of international research. We reference local laws, customs, and attitudes to ensure that research is culturally and legally acceptable.

WIRB is the only independent IRB that delivers IRB, IBC and Education and Consulting services as well as international reviews to its clients. Additionally, in partnership with the World Health Organization, WIRB offers the International Fellows Program to ensure international observance of human subject protection ethics around the world.

Other

General

Shared Oversight

Initial Review

Legally Authorized Rep.

Post-Approval

Consent/Consent Forms

Recruitment Materials

Are Investigator’s Drug Brochures approved?

Federal regulations do not require that IRBs approve Investigator Brochures (IB), although WIRB utilizes IBs when considering research for approval. Because the IB is drug-specific, it is reviewed for each research protocol utilizing that drug; however, the IB itself is not considered for approval or disapproval.

Why do the new consent forms look different?

WIRB is constantly evaluating our processes and systems to improve human subject protections. Recognizing the importance of obtaining true informed consent, the new consent form is intended to change the emphasis from the text of the consent form over to the evaluation of the subject’s understanding.

WIRB will provide a written opinion that a proposed project is exempt from the requirement for IRB review or that it does not require IRB review because the project does not involve research or does not involve human subjects. Complete the Request for Exemption Determination form.

When submitting items to WIRB for review, is the use of the submission form required?

Yes, submission forms are required for initial review, change of prinicipal investigator, change in research, and subject recruitment requests. The cover page of each submission form lists the items required to accompany your request. Log on to Connexus (https://connexus.wirb.com) for convenient smartform submission or click "Download Forms" to access your desired form.

What is a Principal Investigator (PI)?

The PI is the named person who is responsible, under the regulations, for conduct of the research. WIRB prefers that only one investigator be named for this responsibility (Principal Investigator), but will allow a second person upon request (Co-Principal Investigator). Federal regulations do not recognize Co-Principal Investigators. Therefore, the Board approves the two investigators as if each is THE investigator and holds each individually responsible for the conduct of the entire study.

If there are multiple sub-investigators and/or sites, WIRB may require an explanation as to how the PI will personally conduct or oversee the research, as required under 21 CFR 50.3(d), 21 CFR 312.60, and Box 9 of the FDA Form 1572.

How do I submit a change of Principal Investigator (PI)?

WIRB requires written authorization of the change from several parties:
Please provide confirmation from the sponsor that the change is acceptable and has been approved. The sponsor is required to select investigators under 21 CFR 312.53(a).

Provide a letter from the current PI, relinquishing responsibility for the study (if a letter is unavailable, please indicate that it is not available and why).

In addition to the letters authorizing the change, the request should also be accompanied by:

The "protocol" is the written detailed description of the research project.

What is a research study?

The term "study" is used by WIRB to mean the combination of a particular research protocol and investigator.

What is a clinical trial?

The commonly used terms "research trial" and "clinical trial" generally refer to the overall research project at one or more investigator sites. WIRB does not use "trial" in consent forms because of possible misunderstanding by a lay reader.

What is a sponsor?

A sponsor is the company, person, agency, or other party that designs the research, typically funds the research, and bears the sponsor responsibilities under the regulations, but does not actually conduct the investigation.

If there is another IRB involved in my research, what are the options available for WIRB involvement in the oversight?

WIRB can engage in an agreement with another IRB to:
Provide complete dual oversight of research with another IRB, in which both IRBs provide initial and continuing review of all aspects of the research;

Provide split dual oversight of the research with another IRB, in which WIRB provides IRB oversight for specific physical locations, and an institutional IRB provides IRB oversight of the aspects of the study conducted at the institution; or

Assume jurisdiction from an existing institutional IRB for the review of a study or studies.

What is a waiver of consent and what criteria must my study meet if I request one?

For FDA regulated studies, waiver of consent must meet requirements of either 21 CFR 50.23 (a) - (c) (waiver of consent for individual emergency use) or 21 CFR 50.24 (emergency research without consent), or FDA guidance issued 04-25-2006 for In Vitro Diagnostic Device Study Using Leftover Human Specimens That Are Not Individually Identifiable.

For individual emergency waivers of consent, prospective IRB approval is not always necessary if a patient's life can be saved. See the FAQ below titled "What is the difference between "Emergency Use" and "Treatment Use," and how do I determine which situation I have?" for more information, or refer to 21 CFR 50.23 (a)-(c).

If you are requesting a waiver of consent and the research is not an FDA regulated study, then criteria from 45 CFR 46.116(d) must be met. WIRB applies this standard to all requests for waiver of consent for non-FDA regulated research.
The research involves no more than minimal risk to the subjects.

The waiver or alteration will not adversely affect the rights and welfare of the subjects.

The research could not practicably be carried out without the waiver or alteration.

Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c) or 45 CFR 46.117(c)(2), or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24, or 45 CFR 46.116(d). Please see the WIRB FAQ on the Waiver of Documentation of Consent and Waiver of Consent. For requests for waiver of consent, and if you are a covered entity under HIPAA, please complete Request for Full Waiver Authorization Under HIPAA.

2. Signature of Person Who Conducted the Informed Consent Discussion
The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8).

3. Witness Signature
WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written procedures describing who may be a witness and what the witness signature signifies. If a witness signature block is included on the consent form, it must be signed for each consent form, unless the investigator or sponsor written procedures allow otherwise.

4. Signature of Impartial Witness
A subject or a legally authorized representative (LAR) may be unable to read because of blindness, illiteracy, or some other reason. Unless consent has been waived or the protocol excludes enrollment of limited readers or non-readers, involve an impartial witness in the consent process when enrolling limited or non-readers and document the participation of the impartial witness (in compliance with ICH E6 4.8.9) using the designated signature lines on the WIRB-approved consent form. In the absence of designated signature lines, download the WIRB standard impartial witness form from www.wirb.com. . The definition of an impartial witness is provided at ICH E6 1.26.
An impartial witness's signature may not be used to attest to ad hoc translation of the consent into a language different than the language in which the consent form is written.

The impartial witness signature block should be left unsigned unless there is an impartial witness present for the consent process. Please see the frequently asked question, "How do I obtain informed consent from someone who speaks and understands English, but cannot read English?" for further discussion of the impartial witness requirements.

Does my study require a Certificate of Confidentiality, and if so, how do I obtain one?

WIRB’s Board requires a Certificate of Confidentiality (CoC) for certain types of research in order to provide the subjects with extra protection of their confidential information as defined in 45 CFR 46.111(a)(7) and 21 CFR 56.111(a)(7).
The determination to require a CoC is based on whether the research involves a subject population that might be prone to face legal or social harm by another’s discovery of private, confidential, or protected information, such as:

Listed below are links to helpful pages on the Office for Human Research Protection (OHRP) website and the National Institutes of Health (NIH) website. The pages provide information about acquiring a Certificate of Confidentiality.

What is a waiver of documentation of consent and what criteria must my study meet if I request one?

A waiver of documentation of consent is a waiver of the requirement for a signature on a consent form. The regulations allow the Board to approve this type of waiver if:
The research is of minimal risk and involves no procedures for which written consent is usually required; or

The only record linking the subject and the research would be the consent document and the principal risk of the research is the risk of breach of confidentiality.

Subjects enrolling in a study under this type of waiver must be provided with the elements of consent required by the regulations and subjects must consent to participate.

The Board will need to review the information that is provided to subjects to obtain consent to ensure that the required elements of consent are included in the consent discussion. Investigators requesting a waiver of documentation of consent must submit a written statement or script of this information for the Board’s review. A template “Information Sheet” is available on the Download Forms page.

How do I collect data on partners of subjects who become pregnant?

Many protocols now include instructions for investigators to collect data on the outcome of pregnancies that occur in partners of male subjects. WIRB follows 45 CFR 46, which defines research as use of private, identifiable information for research purposes. Because investigators would be obtaining private information from the pregnant partner and infant, the partner would be a subject in the research. Investigators must obtain consent from the pregnant partner before any data collection can occur, and WIRB requires a consent form to be submitted for these subjects if a pregnancy occurs.
If plans for obtaining consent from the pregnant partner (or a request for a consent waiver) are not submitted at initial review, the Board may approve the research, but send a letter reminding the investigator and sponsor that pregnant partners and their infants cannot be followed up on until WIRB approves a consent plan for them. Please note that no action is necessary until such time as a pregnancy occurs.

The letter will be accompanied by a sample consent form template that sites and sponsors may choose to use as a starting point for drafting a consent form for the pregnant partner. The template consent form is available on the Download Forms page. The template consent form cannot be used without WIRB approval.

What is the difference between “Emergency Use” and “Treatment Use,” and how do I determine which situation I have?

"Emergency Use” means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and where there is not sufficient time to obtain IRB approval, as stated in 21 CFR 56.102(d). Life-threatening, for the purposes of section 21 CFR 56.102(d), includes both life-threatening and severely debilitating conditions, as defined below:
Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.

“Treatment Use” (a.k.a. “compassionate use”) is described in the regulations (21 CFR 312.34) as follows:
“During the clinical investigation of the drug, it may be appropriate to use the drug in the treatment of patients not in the clinical trials, in accordance with a treatment protocol or treatment IND. The purpose of this section is to facilitate the availability of promising new drugs to desperately ill patients as early in the drug development process as possible, before general marketing begins, and to obtain additional data on the drug’s safety and effectiveness…. Treatment use of an investigational drug is conditioned on the sponsor and investigators complying with the safeguards of the IND process, including the regulations governing informed consent (21 CFR part 50) and institutional review boards (21 CFR part 56) and the applicable provisions of part 312, including distribution of the drug through qualified experts, maintenance of adequate manufacturing facilities, and submission of IND safety reports.”

Please Note: Regulations require that an emergency use of a test article be reported to the IRB within five working days (21 CFR 56.104(c)). Consequently, you must report an emergency use to WIRB within five working days of its occurrence, even if you communicated with WIRB prior to the emergency use. You may use the form posted here to report the use to WIRB.

Are we required to obtain the consent of subjects who were originally enrolled as children, but have now reached the age where they can consent for themselves?

Yes. Unless consent has been waived, WIRB requires you to obtain the consent of subjects who reach the age of majority during the research. You may use the current WIRB-approved consent form to obtain their consent, or, if the approved consent form is not appropriate for doing so, you may download the consent addendum and present it, along with the current WIRB approved consent form, to the subject in order to obtain his/her consent.

If you use the addendum below, please remove the statement from it regarding authorization to use and disclose information if the consent form signed by the parent/guardian did not include an authorization section.

You do not have to seek WIRB approval of the generic addendum before using it if you use it without alteration (besides removal of the authorization statement if appropriate as outlined above).

Sites often ask why WIRB requires a corrective action plan with reports of unanticipated problems, since the regulations do not specifically require a corrective action plan.

An adverse event or protocol variance is considered to be an unanticipated problem if it suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. If this is the case, WIRB has an ethical responsibility to ensure a corrective action is proposed that will minimize the risk or at least inform subjects about the increased risk (so that they can make a decision about whether to continue to participate in the research). Possible actions taken to minimize the risk might include (but are not limited to) a change in the inclusion or exclusion criteria, addition of new safety monitoring, a change to the administrative processes at the site, or the addition of information about the increased risk to the consent form.

What is WIRB's policy regarding the Statement of Investigator, form FDA 1572?

Investigators are not required to submit a 1572 to WIRB, even when one is required by the FDA for the research being conducted. The FDA Information Sheet "Frequently Asked Questions - Statement of Investigator (Form FDA 1572)" defines the 1572 as:

An agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.

The same information sheet goes on to explain that:

The 1572 has two purposes: 1) to provide the sponsor with information about the investigator's qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation, and 2) to inform the investigator of his/her obligations and obtain the investigator's commitment to follow pertinent FDA regulations.

In existing, approved consent forms, WIRB is replacing its Olympia address with the Puyallup one when revisions are processed.

When WIRB issues a revised consent form, only the substantive issues in the consent form will determine whether the Board directs sites to re-consent all subjects using the revised consent form. The WIRB address change alone does not necessitate formally re-consenting all subjects if they are provided with the notification discussed in point 1 above.

Puyallup [pronounced pew-al-up] is located between Washington’s largest cities -- Olympia, Tacoma and Seattle -- and is within driving distance of several major colleges and universities. Our new, state-of-the-art facility is equipped with the latest technology, to enhance existing processes and improve efficiency.

Our drive for continuous improvement is eclipsed only by our commitment to provide you with the quality and service you deserve. As a client of WIRB, you should expect the gold-standard in ethical review. Should you have any questions, please contact us at 1-800-562-4789. As always, we thank you for your continued business and look forward to serving you in the future.

Do I need to revise my 1572 when WIRB is no longer in Olympia?

WIRB does not require sites to send in copies of its 1572 form.

Please consult your sponsor or CRO about whether it requires you to update your 1572 with our new address.

Please note that WIRB's OHRP/FDA IRB registration will reflect the new address when the move is effective.

How does WIRB handle initial review of consent forms from affiliated institutions?

Multi-site protocols previously approved by WIRB:

If WIRB has previously approved the protocol, WIRB will be able to generate a consent form for you based on the previously approved consent form and site-specific information and institution-specific requirements. If so, you do not have to submit a consent form.

If your institution has language that is chosen by a checklist or other documentation such as cover letters or grants and contracts forms, it must be included with the application to WIRB as usual. WIRB will incorporate this language into the consent form that will be approved for you.

If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on a copy of the WIRB-approved consent form. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.
If your institution requires a pre-review of your application that includes a consent form, please contact WIRB to obtain a copy of the previously approved consent form to include for this review. Client Services can be reached by phone at 1-800-562-4789 or by email at ClientServices@wirb.com. The copy of the consent form that you receive will not include the institutional language requirements, but you do not have to incorporate this language yourself, because WIRB will do so as part of its review. If your institutional pre-review has any questions about this, please refer them to WIRB.

The second question on the submission form deals with consent form choices. You should mark the first box (“If one is available, I would like to use the previously approved WIRB consent form…”) in most cases for previously approved multi-site protocols, unless the study does not require a consent form, in which case mark the last box (“I am not requesting approval of a consent form…”) and indicate the reason.
or
You require protocol-specific changes to the language, in which case mark the second box (“I would like the Board to consider text that differs…”) and provide a copy of the WIRB-approved consent form with only those changes marked.

Multi-site protocols NOT previously approved by WIRB:

If WIRB has not previously approved the protocol, submit the sponsor’s template as a Microsoft Word compatible file (please contact Client Services if you need assistance with submitting in this format). There is no need to incorporate any institution-required language because WIRB will do so as part of its review, including information from the submission form and any language from a checklist or other documentation such as cover letters or grants and contracts forms.

If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on the sponsor’s template in Microsoft Word compatible format. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.
Mark the third box (“This is a new protocol or…”) in question 2 of the submission form.

Single-site protocols:

Submit a consent form as a Microsoft Word compatible file that will be reviewed as new. Mark the third box (“This is a new protocol or…”) in question 2 of the submission form. Please make sure you have reviewed the information on this website on consent forms. You may also request to have WIRB write the consent form (extra fee applies). Please incorporate your institution-required language into the submitted consent form. Please contact your institutional department for the latest version of required language.

If there is another IRB involved in my research, what are the options available for WIRB involvement in the oversight?

WIRB can engage in an agreement with another IRB to:
Provide complete dual oversight of research with another IRB, in which both IRBs provide initial and continuing review of all aspects of the research;

Provide split dual oversight of the research with another IRB, in which WIRB provides IRB oversight for specific physical locations, and an institutional IRB provides IRB oversight of the aspects of the study conducted at the institution; or

Assume jurisdiction from an existing institutional IRB for the review of a study or studies.

When submitting items to WIRB for review, is the use of the submission form required?

WIRB requires that a completed initial review submission form be submitted with each initial review request and change of PI request. The cover page lists the items required in the submission packet.

Also posted on the website is a Change in Research and Subject Recruitment Submission Form. Please use this form (either the "smart form" version or a paper version) to submit changes in research and new or revised subject recruitment materials.

If you need help with any of the WIRB submission forms, please contact Client Services via e-mail at ClientServices@wirb.com or by calling 1-800-562-4789.

Which box should be marked in question #2 concerning consent forms in the Initial Review Submission Form and Investigator Submission Form for Multi-Center Protocols?

First box: “If one is available, I would like to use the previously approved WIRB consent form.” (for multi-center protocols that have previously been reviewed and approved by WIRB)
Mark the first box in most cases. Please also remember that in this case, you can use the shorter Investigator Submission Form for Multi-Center Protocols version of the Initial Review Submission Form.
If you choose this option, you could possibly receive approval documents within 3 to 5 business days if the only information that needs to be incorporated into your consent form is in the submission form (contact names, site locations, phone numbers, payment information). If you are submitting from an affiliated institution that has additional language requirements, your processing time will still be greatly reduced by choosing this option rather than the next one.
You may contact Client Services at 1-800-562-4789 or ClientServices@wirb.com to find out whether the protocol has previously been approved by WIRB.
Site-specific language provided in the submission form (contact names, site locations, phone numbers, payment information) will be incorporated into your consent form.
For affiliated institutions, WIRB will insert all required language (see FAQ “How does WIRB handle consent forms from affiliated institutions?”). ,br />
No consent form needs to be submitted if you mark the first box.

Second box: “I would like the Board to consider text that differs…”
Mark the second box if there is a WIRB-approved consent form, but alterations are being requested.
A consent form must be submitted with the requested alterations clearly marked on the WIRB-approved consent form (obtained from Client Services). Requested changes to the previously approved consent form will be submitted for Board review and may or may not be approved.
Please note that this option is not needed in most circumstances, because WIRB will automatically incorporate site-specific contact information, locations, and payment information into the consent form that will be sent to you. For affiliated institutions, WIRB will incorporate all required language (see frequently asked question “How does WIRB handle consent forms from affiliated institutions?”).
If an affiliated institution requires protocol-specific insertion of language into the text of the consent form, such as study visit durations or a listing of which procedures are standard care, submit a copy of the WIRB-approved consent form with those changes clearly indicated and mark the second box in question 2 of the submission form. All other standard institution language will be incorporated by WIRB and does not need to be indicated on a submitted consent form.
Consent forms must be submitted as Microsoft Word compatible files if you mark the second box.

Third box: “This is a new protocol or…”
Mark the third box if this is a new protocol that has not been previously reviewed by WIRB.
The third box should also be marked if you understand that the protocol has been approved but there is no WIRB-approved consent form, because, for example, the protocol was approved for an administrative site that did not need a consent form.
Please submit consent forms to be reviewed as Microsoft Word compatible files. If you need assistance submitting your files in this format, please contact Client Services. If this consent form is based on the sponsor’s template consent form, please clearly mark any changes to it that you have made.
For affiliated institutions, there is no need to insert standard institutional language; WIRB will insert it along with, if appropriate, information that the institution includes in checklists (see frequently asked question “How does WIRB handle consent forms from affiliated institutions?”).
Consent forms must be submitted as Microsoft Word compatible files if you mark the third box.

Fourth box: “I would like WIRB to write the consent form…” (this box is not present on the Investigator Submission Form for Multi-Center Protocols form).
Mark the fourth box if this is a new protocol without a sponsor’s template, and you want WIRB to write the consent form.
Please contact Client Services at 1-800-562-4789 or ClientServices@wirb.com to discuss the extra fee associated with this service.

Last box: “I am not requesting approval of a consent form…”
Mark the last box if this research does not need a consent form.
Also mark one of the sub-boxes explaining why no approved consent form is needed (for example, "This is on-label use of a Humanitarian Use Device (HUD)").
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Pg. 37 of 98, Section "i"

How does WIRB handle initial review of consent forms from affiliated institutions?

Multi-site protocols previously approved by WIRB:

If WIRB has previously approved the protocol, WIRB will be able to generate a consent form for you based on the previously approved consent form and site-specific information and institution-specific requirements. If so, you do not have to submit a consent form.

If your institution has language that is chosen by a checklist or other documentation such as cover letters or grants and contracts forms, it must be included with the application to WIRB as usual. WIRB will incorporate this language into the consent form that will be approved for you.

If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on a copy of the WIRB-approved consent form. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.

If your institution requires a pre-review of your application that includes a consent form, please contact WIRB to obtain a copy of the previously approved consent form to include for this review. Client Services can be reached by phone at 1-800-562-4789 or by e-mail at ClientServices@wirb.com. The copy of the consent form that you receive will not include the institutional language requirements, but you do not have to incorporate this language yourself, because WIRB will do so as part of its review. If your institutional pre-review has any questions about this, please refer them to WIRB.

The second question on the submission form deals with consent form choices. You should mark the first box (“If one is available, I would like to use the previously approved WIRB consent form…”) in most cases for previously approved multi-site protocols, unless the study does not require a consent form, in which case mark the last box (“I am not requesting approval of a consent form…”) and indicate the reason.
or
You require protocol-specific changes to the language, in which case mark the second box (“I would like the Board to consider text that differs…”) and provide a copy of the WIRB-approved consent form with only those changes marked.

Multi-site protocols NOT previously approved by WIRB:

If WIRB has not previously approved the protocol, submit the sponsor’s template as a Microsoft Word compatible file (please contact Client Services if you need assistance with submitting in this format). There is no need to incorporate any institution-required language because WIRB will do so as part of its review, including information from the submission form and any language from a checklist or other documentation such as cover letters or grants and contracts forms.
If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on the sponsor’s template in Microsoft Word compatible format. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.

Mark the third box (“This is a new protocol or…”) in question 2 of the submission form.
Single-site protocols:

Submit a consent form as a Microsoft Word compatible file that will be reviewed as new. Mark the third box (“This is a new protocol or…”) in question 2 of the submission form. Please make sure you have reviewed the information on this website on consent forms. You may also request to have WIRB write the consent form (extra fee applies). Please incorporate your institution-required language into the submitted consent form. Please contact your institutional department for the latest version of required language.
Pg. 39 of 98, 3rd bullet

What information will WIRB need regarding the study staff, sub-investigators, and the sites?

WIRB will need the name and title of each person involved in the conduct of the research (those members of the study team who have contact with subjects or distribute study articles), a description of the role of each study member, and a curriculum vitae for each sub-investigator. WIRB's initial review submission forms provide a space for sites to list the names, titles, and duties of the study staff.

WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects. 21 CFR 50.3(d).

WIRB will need to know the number of sub-investigators. Possible relevant information includes whether the PI holds periodic meetings, whether all of the sub-investigators are on rotation at a clinic, whether multiple specialties are represented, and if written procedures exist for the conduct of research.

WIRB will need to know some basic information about each site. The initial review submission form solicits this information for the first site; when more than one site will be used, WIRB requires a completed "Additional Sites Listing" form for each additional site.

Can I submit a hand-written submission form?

As of January 1, 2011, WIRB does not accept hand-written initial review submission forms. Hand-written submissions have resulted in significant delays and miscommunications. You may contact Client Services at 1-800-562-4789 or ClientServices@wirb.com for help using the electronic copies of the submission form or the smart form.

How should consent forms be submitted?

Consent forms should be submitted in a Microsoft Word compatible format. This includes files with extensions .doc (Word 2003 and earlier), .docx (Word 2007 and 2010), and .rtf (Rich Text Format, available in most word processing programs). If you have received only a .pdf version from the sponsor, please attempt to get a Word version. Contact Client Services if you need any assistance with submitting your documents in this format.

What information is required when submitting advertisements to WIRB for review?

The WIRB Change in Research and Subject Recruitment Submission Form (either a "smart form" version or a paper version) should be used to submit recruitment materials for review after initial review of the research. The basic information required includes: investigator name, sponsor name, research protocol number, and the name of the person submitting. Ads must be submitted and approved by WIRB before they are used.

For best results, when submitting subject recruitment materials or other subject materials (diaries, questionnaires, etc.) that have been previously reviewed by WIRB, state in the cover letter which items have been previously reviewed by WIRB. WIRB support staff will provide the Board with information about the previous Board review, and the previous decision of the Board will be taken into account when the additional materials are reviewed.

If some recruitment will be done on a website, submit the recruitment portions of the website for WIRB review; do not submit the portions of the website that are not intended for subject recruitment.

WIRB requires a copy of print ads as they will appear, to allow the Board to review the font size, font style, images, etc.

Advertisements that will be used by some or all participating investigators should be identified as such in the cover letter or submission form. Identifying shared advertisements as such will help ensure consistent review of ad materials for all participating sites.

Should I do anything differently if I am submitting audio and/or video recordings?

To avoid costly re-work, audio or video recordings should be submitted first as a script. When the script is approved by WIRB, it may then be used to make the final recording. The recording should then be submitted with a copy of the WIRB approved script for final review as a video tape, audio tape, CD, DVD, Windows Media file (.wm), etc. The audio or video ad is not approved for use until the final recording has been reviewed and approved by WIRB. The submitted audio or video recording is kept in the WIRB files; the recording is NOT returned to the site. Please be sure to retain a copy for use.

Can I make changes to an advertisement without resubmitting to WIRB?

Changes made to an advertisement may alter the effect of the advertisement on potential subjects (changes to pictures, font sizes, font types, etc.). WIRB must review anything that could alter the impact of what was previously reviewed, as required in 21 CFR 56.108(a)(4).

What if changes are desired in sponsor-approved language in a consent form?

Initial Review:

To request that WIRB consider at the time of initial review wording that differs from the sponsor's template consent form or the consent form already approved by WIRB (approved during WIRB's pre-review or approved for other sites), you have two options: 1) You may rewrite all or some of the consent form yourself and submit the changes clearly marked on the WIRB-approved copy of the consent form (or on the sponsor's template if no WIRB-approved version exists); or 2) You may send a cover letter communicating your concerns, and it will be used in the WIRB review and editing of the consent form.

After Initial Review:

To request changes to consent forms for approved research, WIRB requires a completed Change in Research and Subject Recruitment Submission Form (either a "smart form" version or a paper version) and either a copy of the current WIRB-approved consent form with proposed changes clearly marked, or the changes can be detailed in a document specifying the requested changes.

Proposed new changes may be submitted either on a copy of the current WIRB-approved consent form with new changes tracked in redlined format or handwritten on the form, OR the changes can be detailed in a document that indicates each change and the section of the consent form where the change should be made.

For more information on submitting consent form changes, please contact Client Services via email at ClientServices@wirb.com or by calling 1-800-562-4789.

How do I obtain informed consent from someone who speaks and understands English, but cannot read English?

Sometimes potential subjects speak and understand English, but cannot read due to blindness, illiteracy, or some other reason. These individuals may still participate in a research study as long as the Board has not excluded limited or non-readers and there is an impartial witness present for the consent process, in accordance with ICH 4.8.9, which states:

ICH 4.8.9 - If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects is read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject's participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative and that informed consent was freely given by the subject or the subject's legally acceptable representative.

The definition of impartial witness is provided at ICH 1.26, which states:
ICH 1.26 Impartial Witness - A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

WIRB applies this provision of ICH to all research studies.

If an impartial witness signature block is not included on a consent form, and the site encounters a subject who speaks and understands English, but does not read English, please check to see if the protocol allows enrollment of limited or non-readers. If the protocol does not exclude them, download the WIRB standard impartial witness form from the Download Forms page of www.wirb.com to document the participation of an impartial witness in the consent process for the non-reader.

The impartial witness block may not be used to enroll subjects who speak a language other than English. WIRB requires that non-English speaking subjects sign a translated consent form. See the frequently asked question "How is consent obtained from a non-English speaking subject?" for more information.

Why did WIRB change the consent form?

WIRB makes changes to consent forms to meet regulatory requirements, improve the readability, and to be consistent with information in the protocol. In the "redline" version, the superscript numbers and Legend Reasons for Change provide information about why a change was made.

How will I receive documents from WIRB?

Your documents will be sent by email to the address(es) indicated in the WIRB initial review submission forms. Contact WIRB Client Services to request a change to the delivery method.

You can also access your approval documents and other research-related information 24 hours a day via WIRB's web portal called Connexus (https://connexus.wirb.com). Click "LOGIN" in the upper right to set up an account.

If there is another IRB involved in my research, what are the options available for WIRB involvement in the oversight?

WIRB can engage in an agreement with another IRB to:
Provide complete dual oversight of research with another IRB, in which both IRBs provide initial and continuing review of all aspects of the research (for more information about dual oversight arrangements, see below);

Provide split dual oversight of the research with another IRB, in which WIRB provides IRB oversight for specific physical locations, and an institutional IRB provides IRB oversight of the aspects of the study conducted at the institution (for more information about split oversight arrangements, see below); or

Assume jurisdiction from an existing institutional IRB for the review of a study or studies (for more information about a local IRB waiving jurisdiction to WIRB, see below).

What is a waiver of consent and what criteria must my study meet if I request one?

For FDA regulated studies, waiver of consent must meet requirements of either 21 CFR 50.23 (a) - (c) (waiver of consent for individual emergency use) or 21 CFR 50.24 (emergency research without consent), or FDA guidance issued 04-25-2006 for In Vitro Diagnostic Device Study Using Leftover Human Specimens That Are Not Individually Identifiable.

For individual emergency waivers of consent, prospective IRB approval is not always necessary if a patient's life can be saved. See the frequently asked question below titled "What is the difference between "Emergency Use" and "Treatment Use," and how do I determine which situation I have?" for more information, or refer to 21 CFR 50.23 (a)-(c).

If you are requesting a waiver of consent and the research is not an FDA regulated study, then criteria from 45 CFR 46.116(d) must be met. WIRB applies this standard to all requests for waiver of consent for non-FDA regulated research.
The research involves no more than minimal risk to the subjects.

The waiver or alteration will not adversely affect the rights and welfare of the subjects.

The research could not practicably be carried out without the waiver or alteration.

Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c) or 45 CFR 46.117(c)(2), or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24, or 45 CFR 46.116(d). Please see the WIRB FAQ on the Waiver of Documentation of Consent and Waiver of Consent. For requests for waiver of consent, and if you are a covered entity under HIPAA, please complete the WIRB form "Request for Full Waiver of Authorization under HIPAA."

2. Signature of Person Who conducted the Informed Consent Discussion
The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8).

3. Witness Signature
WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written procedures describing who may be a witness and what the witness signature signifies. If a witness signature block is included on the consent form, it must be signed for each consent form, unless the investigator or sponsor written procedures allow otherwise.

4. Signature of Impartial Witness
If a subject or a legally authorized representative (LAR) is unable to read because of blindness, illiteracy, or some other reason, an impartial witness should be present during the entire consent process, and should sign and date the consent form in compliance with ICH E6 4.8.9. The definition of an impartial witness is provided at ICH E6 1.26. In the absence of designated signature lines, download the WIRB standard impartial witness form from the Download Forms page of www.wirb.com.

An impartial witness' signature may not be used to attest to ad hoc translation of the consent into a language different than the language in which the consent form is written.

The impartial witness signature block should be left unsigned unless there is an impartial witness present for the consent process. Please see the Frequently Asked Question, "How do I obtain informed consent from someone who speaks and understands English, but cannot read English?" for further discussion of the impartial witness requirements.

5. Signature of Legally Authorized Representatives (LARs)
In research that allows the enrollment of adult subjects who are not legally competent, the consent form will include a signature block for an LAR. If an adult subject is not legally competent, an LAR must participate in the consent process, agree to the enrollment of the subject in the research, and sign the consent form. If the research allows the enrollment of adult subjects who are legally competent and subjects who are not legally competent, then the LAR signature block will be labeled, "when necessary." In this case, the LAR signature block should not be signed if the subject is legally competent. The LAR signature block will only be signed when the subject is not legally competent.

6. Assent of Children
When research includes children, WIRB follows the regulations for the inclusion of children in research, found at 45 CFR 46, Subpart D, and 21 CFR 50 Subpart D. As part of these regulations, WIRB requires assent from children as required under 45 CFR 46.408 and 21 CFR 50.55. These regulations require that children assent to participation in research unless they lack the mental capacity or unless there is a prospect of direct benefit that is not available outside of the research. WIRB generally finds that children seven years of age and older have the capacity to assent. The child's assent may be documented on the consent form in a variety of ways. The WIRB consent form will include instructions for the documentation of assent. The WIRB Certificate of Approval will note that assent is required.

7. Assent of Adults Incapable of Consent
When research includes legally cognitively impaired adults, WIRB will determine whether the assent of the cognitively impaired adults is required. ICH 4.8.12 requires that when a research study includes subjects who can only be enrolled in the study by a legally authorized representative, "the subject should be informed about the trial to the extent compatible with the subject's understanding and, if capable, the subject should sign and personally date the written consent form." For research involving this study population, WIRB generally includes the following signature block to document that assent was obtained by a representative of the study:

For subjects who have a legally authorized representative, I confirm that I have explained the study to the extent compatible with the subject's understanding, and that the subject has agreed to be in the study.

Signature of Person Conducting Assent Discussion

If the subject is unable to assent at all due to incapacity, the person conducting the assent should still sign this block to indicate that an attempt was made to obtain the subject's assent.

8. Signature of Principal Investigator
As of June 19, 2001, WIRB does not require an investigator's signature on the consent form; however, if a consent form is submitted with an investigator signature line, WIRB will not remove it. If an investigator signature line is on the consent form, the investigator or an "equally qualified" sub-investigator must sign the consent form. WIRB does not require that the investigator signature be dated the same as the subject signature.

Why is there a signature block for the person who conducted the consent discussion?

WIRB will automatically include a signature block to be signed by "the person who conducted the informed consent discussion," in compliance with ICH 4.8.8. WIRB does not include a witness signature block unless requested by the site or sponsor.

How do I consent a cognitively impaired subject?

FDA regulation 21 CFR § 50.20 and HHS regulation 45 CFR 46.116 state that:
No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

If an adult subject is not medically capable and/or legally competent to consent to participate in a study, the federal regulations require that a legally authorized representative consent for the subject. The definition of “legally authorized representative,” as described in FDA 21 CFR § 50.3 and HHS 45 CFR 102(c) is:

An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

The applicable law is the law of the state, as well as any other local law. Thus, the definition of “legally authorized representative” will be determined by state law or other local law. If a subject is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the subject’s behalf. The Office for Human Research Protections (OHRP) has determined that state laws addressing consent for treatment decisions concerning the same procedures involved in the research are an acceptable basis for determining who may serve as a “legally authorized representative.”

Starting August 1, 2005, investigators receiving WIRB approval to conduct a new protocol allowing for the inclusion of adults who lack the capacity to personally provide consent may look forward to receiving a letter from WIRB describing their state's laws regarding legally authorized representatives.

For questions regarding the legal status of an individual subject and the applicability of local law to an individual subject’s enrollment in research, contact a healthcare attorney admitted to the bar in that state. Sites should be aware that changes in statutes and regulations occur frequently, and that court decisions may determine or change the interpretation of such statutes and regulations. Legal counsel should always be consulted to determine the current state of applicable law.

What is a legally authorized representative (LAR)?

FDA regulation 21 CFR § 50.20 and HHS regulation 45 CFR 46.116 state that:
No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

If an adult subject is not medically capable and/or legally competent to consent to participate in a study, the federal regulations require that a legally authorized representative consent for the subject. The definition of “legally authorized representative,” as described in FDA 21 CFR § 50.3 and HHS 45 CFR 102(c) is:

An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

The applicable law is the law of the state, as well as any other local law. Thus, the definition of “legally authorized representative” will be determined by state law or other local law. If a subject is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the subject’s behalf. The Office for Human Research Protections (OHRP) has determined that state laws addressing consent for treatment decisions concerning the same procedures involved in the research are an acceptable basis for determining who may serve as a “legally authorized representative.”

Starting August 1, 2005, investigators receiving WIRB approval to conduct a new protocol allowing for the inclusion of adults who lack the capacity to personally provide consent may look forward to receiving a letter from WIRB describing their state's laws regarding legally authorized representatives.

For questions regarding the legal status of an individual subject and the applicability of local law to an individual subject’s enrollment in research, contact a healthcare attorney admitted to the bar in that state. Sites should be aware that changes in statutes and regulations occur frequently, and that court decisions may determine or change the interpretation of such statutes and regulations. Legal counsel should always be consulted to determine the current state of applicable law.
Pg 14 of 98, Section "F"

How is consent obtained from a non-English speaking subject?

WIRB requires that non-English speaking subjects sign a WIRB-approved translated consent form. An ad hoc oral translation of the consent form is not acceptable. WIRB's Translations department can arrange to have a WIRB-approved consent form or subject material translated into any language, or the site/sponsor can submit to WIRB a translated document along with a signed translator certification statement for verification and approval. Specific submission requirements may be obtained from the WIRB Translations department.

You must also explain your plans for 1) conducting the consent discussion in the language understandable to the subject, and for 2) ongoing communication with the subject throughout the research and in case of emergency.

For example, your site might indicate “At least one member of the research team is fluent in the language that will be used for communication, and that research staff member(s) will be available during emergencies,” “The research team has 24-hour access to a translation service with sufficient medical expertise to discuss the research in this study,” or provide another appropriate plan.

Please provide these plans each time you request a translation into a new language for a particular study. Your translation requests may be delayed if you have not already provided an acceptable language-specific and research-specific plan.

What is WIRB's position on placebo-controlled studies?

Click here to view the checklist WIRB uses to review placebo-controlled studies in .pdf format or Microsoft Word format. This checklist is fully discussed in the article "Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach."

The article was published in the Drug Information Journal, Volume 36, Number 2, 2002.

My site is in California, but the contents of the California Experimental Subjects’ Bill of Rights don’t apply to my research project. Can I ask WIRB to omit the Bill from my approved consent form?

Yes, WIRB will consider omitting the Bill from your approved consent form. Sites that believe the Bill is not applicable to their research and that desire to see it omitted from their consent form can submit a change in research request. WIRB review fees apply for requests submitted as changes in research.

As of June 1, 2010, the California Experimental Subject's Bill of Rights is not included in the approved consent form. However, consent forms continue to contain a reference to it ("If you agree to be in this study, you will receive a signed and dated copy of this consent form and the Experimental Subject's Bill of Rights for your records"), and it continues to be provided to California sites with the Initial Review approval documents.

The text of the applicable California law can be found in the California Health and Safety code, section 24174.

Does my study require a Certificate of Confidentiality, and if so, how do I obtain one?

WIRB’s Board requires a Certificate of Confidentiality (CoC) for certain types of research in order to provide the subjects with extra protection of their confidential information as defined in 45 CFR 46.111(a)(7) and 21 CFR 56.111(a)(7).
The determination to require a CoC is based on whether the research involves a subject population that might be prone to face legal or social harm by another’s discovery of private, confidential, or protected information, such as:

Listed below are links to helpful pages on the Office for Human Research Protection (OHRP) website and the National Institutes of Health (NIH) website. The pages provide information about acquiring a Certificate of Confidentiality.

What is a waiver of documentation of consent and what criteria must my study meet if I request one?

A waiver of documentation of consent is a waiver of the requirement for a signature on a consent form. The regulations allow the Board to approve this type of waiver if:
The research is minimal risk and involves no procedures for which written consent is usually required; or

The only record linking the subject and the research would be the consent document and the principal risk of the research is the risk of breach of confidentiality.

Subjects enrolling in a study under this type of waiver must be provided with the elements of consent required by the regulations and subjects must consent to participate.

The Board will need to review the information that is provided to subjects to obtain consent to ensure that the required elements of consent are included in the consent discussion. Investigators requesting a waiver of documentation of consent must submit a written statement or script of this information for the Board’s review. A template “Information Sheet” is available on the Download Forms page.

How do I collect data on partners of subjects who become pregnant?

Many protocols now include instructions for investigators to collect data on the outcome of pregnancies that occur in partners of male subjects. WIRB follows 45 CFR 46, which defines research as use of private, identifiable information for research purposes. Because investigators would be obtaining private information from the pregnant partner and infant, the partner would be a subject in the research. Investigators must obtain consent from the pregnant partner before any data collection can occur, and WIRB requires a consent form to be submitted for these subjects if a pregnancy occurs.
If plans for obtaining consent from the pregnant partner (or a request for a consent waiver) are not submitted at initial review, the Board may approve the research, but send a letter reminding the investigator and sponsor that pregnant partners and their infants cannot be followed—up until WIRB approves a consent plan for them. Please note that no action is necessary until such time as a pregnancy occurs.

The letter will be accompanied by a sample consent form template that sites and sponsors may choose to use as a starting point for drafting a consent form for the pregnant partner. The template consent form is available on the Download Forms page. The template consent form cannot be used without WIRB approval.

What is the difference between “Emergency Use” and “Treatment Use,” and how do I determine which situation I have?

“Emergency Use” means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and where there is not sufficient time to obtain IRB approval, as stated in 21 CFR 56.102(d). Life-threatening, for the purposes of section 21 CFR 56.102(d), includes both life-threatening and severely debilitating conditions, as defined below:
Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand, or foot, loss of hearing, paralysis, or stroke.
“Treatment Use” (a.k.a. “compassionate use”) is described in the regulations (21 CFR 312.34) as follows:
“During the clinical investigation of the drug, it may be appropriate to use the drug in the treatment of patients not in the clinical trials, in accordance with a treatment protocol or treatment IND. The purpose of this section is to facilitate the availability of promising new drugs to desperately ill patients as early in the drug development process as possible, before general marketing begins, and to obtain additional data on the drug’s safety and effectiveness…. Treatment use of an investigational drug is conditioned on the sponsor and investigators complying with the safeguards of the IND process, including the regulations governing informed consent (21 CFR part 50) and institutional review boards (21 CFR part 56) and the applicable provisions of part 312, including distribution of the drug through qualified experts, maintenance of adequate manufacturing facilities, and submission of IND safety reports.”
Please Note: Regulations require that an emergency use of a test article be reported to the IRB within five working days (21 CFR 56.104(c)). Consequently, you must report an emergency use to WIRB within five working days of its occurrence, even if you communicated with WIRB prior to the emergency use. You may use the form posted here to report the use to WIRB.

What is WIRB's policy regarding the Statement of Investigator, form FDA 1572?

Investigators are not required to submit a 1572 to WIRB, even when one is required by the FDA for the research being conducted. The FDA Information Sheet "Frequently Asked Questions - Statement of Investigator (Form FDA 1572)" defines the 1572 as:

An agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.

The same information sheet goes on to explain that:

The 1572 has two purposes: 1) to provide the sponsor with information about the investigator's qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation, and 2) to inform the investigator of his/her obligations and obtain the investigator's commitment to follow pertinent FDA regulations.

If adult subjects do not have the capacity to consent, WIRB expects that consent will be obtained from a legally authorized representative (LAR), and that the assent of the subject will be obtained to the extent compatible with their capacity.

What is a legally authorized representative (LAR)?

FDA regulation 21 CFR § 50.20 and HHS regulation 45 CFR 46.116 state that:
No investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

If an adult subject is not medically capable and/or legally competent to consent to participate in a study, the federal regulations require that a legally authorized representative consent for the subject. The definition of “legally authorized representative” as described in FDA 21 CFR § 50.3 and HHS 45 CFR 102(c) is:

An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

The applicable law is the law of the state, as well as any other local law. Thus, the definition of “legally authorized representative” will be determined by state law or other local law. If a subject is medically incapable and/or legally incompetent, then a legally authorized representative, as determined under state or local law, must consent on the subject’s behalf. The Office for Human Research Protections (OHRP) has determined that state laws addressing consent for treatment decisions concerning the same procedures involved in the research are an acceptable basis for determining who may serve as a “legally authorized representative.”

Starting August 1, 2005, investigators receiving WIRB approval to conduct a new protocol allowing for the inclusion of adults who lack the capacity to personally provide consent may look forward to receiving a letter from WIRB describing their state's laws regarding legally authorized representatives.

For questions regarding the legal status of an individual subject and the applicability of local law to an individual subject’s enrollment in research, contact a healthcare attorney admitted to the bar in that state. Sites should be aware that changes in statutes and regulations occur frequently, and that court decisions may determine or change the interpretation of such statutes and regulations. Legal counsel should always be consulted to determine the current state of applicable law.

When submitting items to WIRB for review, is the use of the submission form required?

WIRB requires that a completed initial review submission form be submitted with each initial review request and change of principal investigator request. The cover page lists the items required in the submission packet.

Also posted on the website is a Change in Research and Subject Recruitment Submission Form. Please use this form (either the "smart form" version or a paper version) to submit changes in research and new or revised subject recruitment materials.

If you need help with any of the WIRB submission forms, please contact Client Services via e-mail at ClientServices@wirb.com, or by calling 1-800-562-4789.

How do I submit a change of Principal Investigator (PI)?

WIRB requires written authorization of the change from several parties:
Please provide confirmation from the sponsor that the change is acceptable and has been approved. The sponsor is required to select investigators under 21 CFR 312.53(a).
Provide a letter from the current PI, relinquishing responsibility for the study (if a letter is unavailable, please indicate that it is not available and why).
In addition to the letters authorizing the change, the request should also be accompanied by:
1. A WIRB initial review submission form (ether a "smart form" version or a paper version) completed by the new PI (if you choose not to use the smart form, you may use the Investigator Submission Form for Multi-Center Protocols version of the initial review submission form).
2. Documentation of the new investigator's qualifications to conduct the study (a CV and, when applicable, a professional license).
3. A request to update the investigator information in the existing consent documents to reflect the new investigator information.

What information will WIRB need regarding the study staff, sub-investigators, and the sites?

WIRB will need the name and title of each person involved in the conduct of the research (those members of the study team who have contact with subjects or distribute study articles), a description of the role of each study member, and a curriculum vitae for each sub-investigator. WIRB's initial review submission forms provide a space for sites to list the names, titles, and duties of the study staff.

WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects (21 CFR 50.3(d)).

WIRB will need to know the number of sub-investigators. Possible relevant information includes whether the PI holds periodic meetings, whether all of the sub-investigators are on rotation at a clinic, whether multiple specialties are represented, and if written procedures exist for the conduct of research.

WIRB will need to know some basic information about each site. The initial review submission form solicits this information for the first site; when more than one site will be used, WIRB requires a completed "Additional Sites Listing" form for each additional site.

Can I submit a hand-written submission form?

As of January 1, 2011, WIRB does not accept hand-written initial review submission forms. Hand-written submissions have resulted in significant delays and miscommunications. You may contact Client Services at 1-800-562-4789 or ClientServices@wirb.com, for help using the electronic copies of the submission form or the smart form.

How should consent forms be submitted?

Consent forms should be submitted in a Microsoft Word compatible format. This includes files with extensions .doc (Word 2003 and earlier), .docx (Word 2007 and 2010), and .rtf (Rich Text Format, available in most word processing programs). If you have received only a .pdf version from the sponsor, please attempt to get a Word version. Contact Client Services if you need any assistance with submitting your documents in this format.

What information is required when submitting advertisements to WIRB for review?

WIRB will need the name and title of each person involved in the conduct of the research (those members of the study team who have contact with subjects or distribute study articles), a description of the role of each study member, and a curriculum vitae for each sub-investigator. WIRB's initial review submission forms provide a space for sites to list the names, titles, and duties of the study staff.

WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects (21 CFR 50.3(d)).

WIRB will need to know the number of sub-investigators. Possible relevant information includes whether the PI holds periodic meetings, whether all of the sub-investigators are on rotation at a clinic, whether multiple specialties are represented, and if written procedures exist for the conduct of research.

WIRB will need to know some basic information about each site. The initial review submission form solicits this information for the first site; when more than one site will be used, WIRB requires a completed "Additional Sites Listing" form for each additional site.

How will I be notified of my ad's approval?

Ads are approved in one of two ways: "As Submitted" (no changes) or "As Modified." Board-directed changes are indicated on the ad returned with the certificate of approval.

Ads submitted with the protocol and consent form at the time of initial review will be returned in the initial approval packet. Approved ad(s) will be listed on the certificate of approval, and show any changes required by WIRB. (Prior to 2013, acceptable audio and video scripts were found "approvable" and stamped as such; "approvable" scripts were not listed on the certificate of approval; currently they are approved, but audio and video materials may not be used until after the audio or video recording has been reviewed by the Board.)

WIRB does not routinely apply approval stamps to approved advertisements. The Certificate of Approval listing approval of the ad is documentation of WIRB's review and approval of the advertisement.

Should I do anything differently if I am submitting audio and/or video recordings?

To avoid costly re-work, audio or video recordings should be submitted first as a script. When the script is approved by WIRB, it may then be used to make the final recording. The recording should then be submitted with a copy of the WIRB approved script for final review as a video tape, audio tape, CD, DVD, Windows Media file (.wm), etc. The audio or video ad is not approved for use until the final recording has been reviewed and approved by WIRB. The submitted audio or video recording is kept in the WIRB files; the recording is NOT returned to the site. Please be sure to retain a copy for use.

Can I make changes to an advertisement without resubmitting to WIRB?

Changes made to an advertisement may alter the effect of the advertisement on potential subjects (changes to pictures, font sizes, font types, etc.). WIRB must review anything that could alter the impact of what was previously reviewed, as required in 21 CFR 56.108(a)(4).

See also the Subject Recruitment Materials section of this website for more information about modifications to approved recruitment materials, or contact Client Services via e-mail at ClientServices@wirb.com, or call 1-800-562-4789.

What if changes are desired in sponsor-approved language in a consent form?

Initial Review:

To request that WIRB consider at the time of initial review wording that differs from the sponsor's template consent form or the consent form already approved by WIRB (approved during WIRB's pre-review or approved for other sites), you have two options: 1) You may rewrite all or some of the consent form yourself and submit the changes clearly marked on the WIRB-approved copy of the consent form (or on the sponsor's template if no WIRB-approved version exists), or 2) You may send a cover letter communicating your concerns, and it will be used in the WIRB review and editing of the consent form.

After Initial Review:

To request changes to consent forms for approved research, WIRB requires a completed Change in Research and Subject Recruitment Submission Form (either a "smart form" version or a paper version) and either a copy of the current WIRB-approved consent form with proposed changes clearly marked, or the changes can be detailed in a document specifying the requested changes.

Proposed new changes may be submitted either on a copy of the current WIRB-approved consent form with new changes tracked in redlined format or handwritten on the form, OR the changes can be detailed in a document that indicates each change and the section of the consent form where the change should be made.

For more information on submitting consent form changes, please contact Client Services via e-mail at ClientServices@wirb.com, or by calling 1-800-562-4789.

Why did WIRB change the consent form?

WIRB makes changes to consent forms to meet regulatory requirements, improve the readability, and to be consistent with information in the protocol. In the "redline" version, the superscript numbers and Legend Reasons for Change provide information about why a change was made.

WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c) or 45 CFR 46.117(c)(2), or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24, or 45 CFR 46.116(d). Please see the WIRB FAQ on the Waiver of Documentation of Consent and Waiver of Consent. For requests for waiver of consent, and if you are a covered entity under HIPAA, please complete Request for Full Waiver Authorization Under HIPAA.

2. Signature of Person Who Conducted the Informed Consent Discussion
The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8).

3. Witness Signature
WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written procedures describing who may be a witness and what the witness signature signifies. If a witness signature block is included on the consent form, it must be signed for each consent form, unless the investigator or sponsor written procedures allow otherwise.

4. Signature of Impartial Witness
A subject or a legally authorized representative (LAR) may be unable to read because of blindness, illiteracy, or some other reason. Unless consent has been waived or the protocol excludes enrollment of limited readers or non-readers, involve an impartial witness in the consent process when enrolling limited or non-readers and document the participation of the impartial witness (in compliance with ICH E6 4.8.9) using the designated signature lines on the WIRB-approved consent form. In the absence of designated signature lines, download the WIRB standard impartial witness form from www.wirb.com. . The definition of an impartial witness is provided at ICH E6 1.26.
An impartial witness's signature may not be used to attest to ad hoc translation of the consent into a language different than the language in which the consent form is written.

The impartial witness signature block should be left unsigned unless there is an impartial witness present for the consent process. Please see the frequently asked question, "How do I obtain informed consent from someone who speaks and

Why is there a signature block for the person who conducted the consent discussion?

WIRB will automatically include a signature block to be signed by "the person who conducted the informed consent discussion," in compliance with ICH 4.8.8. WIRB does not include a witness signature block unless requested by the site or sponsor.

My site is in California, but the contents of the California Experimental Subjects’ Bill of Rights don’t apply to my research project. Can I ask WIRB to omit the Bill from my approved consent form?

Yes, WIRB will consider omitting the Bill from your approved consent form. Sites that believe the Bill is not applicable to their research and that desire to see it omitted from their consent form can submit a change in research request. WIRB review fees apply for requests submitted as changes in research.

As of June 1, 2010, the California Experimental Subject's Bill of Rights is not included in the approved consent form. However consent forms continue to contain a reference to it ("If you agree to be in this study, you will receive a signed and dated copy of this consent form and the Experimental Subject's Bill of Rights for your records"), and it continues to be provided to California sites with the initial review approval documents.

The text of the applicable California law can be found in the California Health and Safety code Section 24174.

My HUD is not research; how do I fill out the WIRB Continuing Review Report Form?

Humanitarian Use Devices (HUDs) are approved devices whose use must comply with 21 CFR 814, Subpart H “Humanitarian Use Devices,” and 21 CFR Part 803, “Medical Device Reporting.” Federal regulation 21 CFR 814.124 requires IRB review and approval of use of the device.

WIRB requires all approved, active sites to provide progress reports at least annually (21 CFR § 56.109(f)). Continuing Review Report Forms are sent to sites approximately two weeks before their due date.

WIRB understands that some of the questions on its Continuing Review Report Form are not pertinent to the use of a HUD according to its approved labeling and indication(s) to treat or diagnose patients, but you must complete the applicable questions and mark the rest “NA.” See this sample form indicating which questions can routinely be marked “NA.” If your use of the HUD qualifies as research (investigational use or clinical investigation of a HUD), you cannot mark the blanks “NA.”

In situations where progress reports are not returned with accurate information in a timely manner, federal regulations grant the Board authority to suspend or terminate approval of the use of the device at the site (21 CFR § 56.113).

If the Board takes action to suspend approval for use of a HUD at your site, you would not be allowed to use the HUD on any new patients until the Board receives the information it requires and votes to lift the suspension.

Therefore, it is imperative that you submit the accurate and complete continuing review reports by the due date stated on the form.

Humanitarian Use Devices (HUDs) are approved devices whose use must comply with 21 CFR 814, Subpart H “Humanitarian Use Devices,” and 21 CFR Part 803, “Medical Device Reporting.” Federal Regulation 21 CFR 814.124 requires IRB review and approval of use of the device.

WIRB requires all approved, active sites provide progress reports at least annually (21 CFR § 56.109(f)). Continuing Review Report Forms are sent to sites approximately two weeks before their due date.

WIRB understands that some of the questions on its Continuing Review Report Form are not pertinent to the use of a HUD according to its approved labeling and indication(s) to treat or diagnose patients, but you must complete the applicable questions and mark the rest “NA.” See the document below for a sample form indicating which questions can routinely be marked “NA.” If your use of the HUD qualifies as research (investigational use or clinical investigation of a HUD), you cannot mark the blanks “NA.”

PDF Version

In situations where progress reports are not returned with accurate information in a timely manner, Federal Regulations grant the Board authority to suspend or terminate approval of the use of the device at the site (21 CFR § 56.113).

If the Board takes action to suspend approval for use of a HUD at your site, you would not be allowed to use the HUD on any new patients until the Board receives the information it requires and votes to lift the suspension.

Therefore, it is imperative that you submit the accurate and complete continuing review reports by the due date stated on the form.

Are we required to obtain the consent of subjects who were originally enrolled as children, but have now reached the age where they can consent for themselves?

Yes. Unless consent has been waived, WIRB requires you to obtain the consent of subjects who reach the age of majority during the research. You may use the current WIRB-approved consent form to obtain their consent, or, if the approved consent form is not appropriate for doing so, you may download the consent addendum and present it, along with the current WIRB approved consent form, to the subject in order to obtain his/her consent.

If you use the addendum below, please remove the statement from it regarding authorization to use and disclose information if the consent form signed by the parent/guardian did not include an authorization section.

You do not have to seek WIRB approval of the generic addendum before using it if you use it without alteration (besides removal of the authorization statement if appropriate as outlined above).

Sites often ask why WIRB requires a corrective action plan with reports of unanticipated problems, since the regulations do not specifically require a corrective action plan.

An adverse event or protocol variance is considered to be an unanticipated problem if it suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. If this is the case, WIRB has an ethical responsibility to ensure a corrective action is proposed that will minimize the risk or at least inform subjects about the increased risk (so that they can make a decision about whether to continue to participate in the research). Possible actions taken to minimize the risk might include (but are not limited to) a change in the inclusion or exclusion criteria, addition of new safety monitoring, a change to the administrative processes at the site, or the addition of information about the increased risk to the consent form.

The PI is unexpectedly no longer able to oversee the study. What do I do?

WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects [21 CFR 56.102 (h); for Canadian investigators: Part C Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations (if applicable), Medical Devices Regulations (if applicable)].

As soon as possible, WIRB will need either a study closure request from the site, or a submission of a new PI for the Board’s review. As with any unanticipated research-related event, please submit this information within 10 days of the investigator’s departure from the study.

WIRB normally requires a letter of relinquishment from the old PI, but if a letter is not available, provide the following information in its place:

When did the PI leave this study?

Why did the PI leave this study?

Who has provided oversight in the PI's absence?

Have there been any subject safety concerns during the PI's absence?

How does WIRB handle initial review of consent forms from affiliated institutions?

Multi-site protocols previously approved by WIRB:

If WIRB has previously approved the protocol, WIRB will be able generate a consent form for you based on the previously approved consent form and site-specific information and institution-specific requirements. If so, you do not have to submit a consent form.

If your institution has language that is chosen by a checklist or other documentation such as cover letters or grants and contracts forms, it must be included with the application to WIRB as usual. WIRB will incorporate this language into the consent form that will be approved for you.

If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on a copy of the WIRB-approved consent form. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.

If your institution requires a pre-review of your application that includes a consent form, please contact WIRB to obtain a copy of the previously approved consent form to include for this review. Client Services can be reached by phone at 1-800-562-4789 or by e-mail at ClientServices@wirb.com. The copy of the consent form that you receive will not include the institutional language requirements, but you do not have to incorporate this language yourself, because WIRB will do so as part of its review. If your institutional pre-review has any questions about this, please refer them to WIRB.
The second question on the submission form deals with consent form choices. You should mark the first box (“If one is available, I would like to use the previously approved WIRB consent form…”) in most cases for previously approved multi-site protocols, unless the study does not require a consent form, in which case mark the last box (“I am not requesting approval of a consent form…”) and indicate the reason.
or
You require protocol-specific changes to the language, in which case mark the second box (“I would like the Board to consider text that differs…”) and provide a copy of the WIRB-approved consent form with only those changes marked.

Multi-site protocols NOT previously approved by WIRB:

If WIRB has not previously approved the protocol, submit the sponsor’s template as a Microsoft Word compatible file (please contact Client Services if you need assistance with submitting in this format). There is no need to incorporate any institution-required language because WIRB will do so as part of its review, including information from the submission form and any language from a checklist or other documentation such as cover letters or grants and contracts forms.
If your institution requires protocol-specific insertion of language to the text of the consent form, such as study visit durations or a listing of which procedures are standard care, clearly mark those changes on the sponsor’s template in Microsoft Word compatible format. All other standard institution language will be incorporated by WIRB and does not need to be marked on the submitted consent form.
Mark the third box (“This is a new protocol or…”) in question 2 of the submission form.

Single-site protocols:

Submit a consent form as a Microsoft Word compatible file that will be reviewed as new. Mark the third box (“This is a new protocol or…”) in question 2 of the submission form. Please make sure you have reviewed the information on this website regarding consent forms. You may also request to have WIRB write the consent form (extra fee applies). Please incorporate your institution-required language into the submitted consent form. Please contact your institutional department for the latest version of required language.
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How should consent forms be submitted?

Consent forms should be submitted in a Microsoft Word compatible format. This includes files with extensions .doc (Word 2003 and earlier), .docx (Word 2007 and 2010), and .rtf (Rich Text Format, available in most word processing programs). If you have received only a .pdf version from the sponsor, please attempt to get a Word version. Contact Client Services if you need any assistance with submitting your documents in this format.

What if changes are desired in sponsor-approved language in a consent form?

Initial Review:

To request that WIRB consider at the time of initial review wording that differs from the sponsor's template consent form or the consent form already approved by WIRB (approved during WIRB's pre-review or approved for other sites), you have two options: 1) You may rewrite all or some of the consent form yourself and submit the changes clearly marked on the WIRB-approved copy of the consent form (or on the sponsor's template if no WIRB-approved version exists), or 2) You may send a cover letter communicating your concerns, and it will be used in the WIRB review and editing of the consent form.

After Initial Review:

To request changes to consent forms for approved research, WIRB requires a completed Change in Research and Subject Recruitment Submission Form (either a "smart form" version or a paper version) and either a copy of the current WIRB-approved consent form with proposed changes clearly marked, or the changes can be detailed in a document specifying the requested changes.

Proposed new changes may be submitted either on a copy of the current WIRB-approved consent form with new changes tracked in redlined format or handwritten on the form, OR the changes can be detailed in a document that indicates each change and the section of the consent form where the change should be made.

For more information on submitting consent form changes, please contact Client Services via e-mail at ClientServices@wirb.com or by calling 1-800-562-4789.

How do I obtain informed consent from someone who speaks and understands English, but cannot read English?

Sometimes potential subjects speak and understand English, but cannot read due to blindness, illiteracy, or some other reason. These individuals may still participate in a research study as long as the Board has not excluded limited or non-readers and there is an impartial witness present for the consent process, in accordance with ICH 4.8.9, which states:

ICH 4.8.9 - If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects is read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject's participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative and that informed consent was freely given by the subject or the subject's legally acceptable representative.

The definition of impartial witness is provided at ICH 1.26, which states:
ICH 1.26 Impartial Witness - A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

WIRB applies this provision of ICH to all research studies.

If an impartial witness signature block is not included on a consent form, and the site encounters a subject who speaks and understands English, but does not read English, please check to see if the protocol allows enrollment of limited or non-readers. If the protocol does not exclude them, download the WIRB standard impartial witness form from the Download Forms page of www.wirb.com to document the participation of an impartial witness in the consent process for the non-reader.

The impartial witness block may not be used to enroll subjects who speak a language other than English. WIRB requires that non-English speaking subjects sign a translated consent form. See the frequently asked question "How is consent obtained from a non-English speaking subject?" for more information.

Why did WIRB change the consent form?

WIRB makes changes to consent forms to meet regulatory requirements, improve the readability, and to be consistent with information in the protocol. In the "redline" version, the superscript numbers and Legend Reasons for Change provide information about why a change was made.

What is a waiver of consent and what criteria must my study meet if I request one?

For FDA-regulated studies, waiver of consent must meet requirements of either 21 CFR 50.23 (a) - (c) (waiver of consent for individual emergency use) or 21 CFR 50.24 (emergency research without consent), or FDA guidance issued 04-25-2006 for In Vitro Diagnostic Device Study Using Leftover Human Specimens That Are Not Individually Identifiable.

For individual emergency waivers of consent, prospective IRB approval is not always necessary if a patient's life can be saved. See the frequently asked question below titled "What is the difference between "Emergency Use" and "Treatment Use," and how do I determine which situation I have?" for more information, or refer to 21 CFR 50.23 (a)-(c).

If you are requesting a waiver of consent and the research is not an FDA-regulated study, then criteria from 45 CFR 46.116(d) must be met. WIRB applies this standard to all requests for waiver of consent for non-FDA-regulated research.
The research involves no more than minimal risk to the subjects.

The waiver or alteration will not adversely affect the rights and welfare of the subjects.

The research could not practicably be carried out without the waiver or alteration.

Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c) or 45 CFR 46.117(c)(2), or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24, or 45 CFR 46.116(d). Please see the WIRB FAQ on the Waiver of Documentation of Consent and Waiver of Consent. For requests for waiver of consent, and if you are a covered entity under HIPAA, please complete the WIRB form "Request for Full Waiver of Authorization under HIPAA."

2. Signature of Person Who conducted the Informed Consent Discussion
The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8).

3. Witness Signature
WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written procedures describing who may be a witness and what the witness signature signifies. If a witness signature block is included on the consent form, it must be signed for each consent form, unless the investigator or sponsor written procedures allow otherwise.

4. Signature of Impartial Witness
If a subject or a legally authorized representative (LAR) is unable to read because of blindness, illiteracy, or some other reason, an impartial witness should be present during the entire consent process, and should sign and date the consent form in compliance with ICH E6 4.8.9. The definition of an impartial witness is provided at ICH E6 1.26. In the absence of designated signature lines, download the WIRB standard impartial witness form from the Download Forms page of www.wirb.com.

An impartial witness' signature may not be used to attest to ad hoc translation of the consent into a language different than the language in which the consent form is written.

The impartial witness signature block should be left unsigned unless there is an impartial witness present for the consent process. Please see the Frequently Asked Question, "How do I obtain informed consent from someone who speaks and understands English, but cannot read English?" for further discussion of the impartial witness requirements.

5. Signature of Legally Authorized Representatives (LARs)
In research that allows the enrollment of adult subjects who are not legally competent, the consent form will include a signature block for an LAR. If an adult subject is not legally competent, an LAR must participate in the consent process, agree to the enrollment of the subject in the research, and sign the consent form. If the research allows the enrollment of adult subjects who are legally competent and subjects who are not legally competent, then the LAR signature block will be labeled, "when necessary." In this case, the LAR signature block should not be signed if the subject is legally competent. The LAR signature block will only be signed when the subject is not legally competent.

6. Assent of Children
When research includes children, WIRB follows the regulations for the inclusion of children in research, found at 45 CFR 46, Subpart D, and 21 CFR 50 Subpart D. As part of these regulations, WIRB requires assent from children as required under 45 CFR 46.408 and 21 CFR 50.55. These regulations require that children assent to participation in research unless they lack the mental capacity or unless there is a prospect of direct benefit that is not available outside of the research. WIRB generally finds that children seven years of age and older have the capacity to assent. The child's assent may be documented on the consent form in a variety of ways. The WIRB consent form will include instructions for the documentation of assent. The WIRB Certificate of Approval will note that assent is required.

7. Assent of Adults Incapable of Consent
When research includes legally cognitively impaired adults, WIRB will determine whether the assent of the cognitively impaired adults is required. ICH 4.8.12 requires that when a research study includes subjects who can only be enrolled in the study by a legally authorized representative, "the subject should be informed about the trial to the extent compatible with the subject's understanding and, if capable, the subject should sign and personally date the written consent form." For research involving this study population, WIRB generally includes the following signature block to document that assent was obtained by a representative of the study:

For subjects who have a legally authorized representative, I confirm that I have explained the study to the extent compatible with the subject's understanding, and that the subject has agreed to be in the study.

Signature of Person Conducting Assent Discussion

If the subject is unable to assent at all due to incapacity, the person conducting the assent should still sign this block to indicate that an attempt was made to obtain the subject's assent.

8. Signature of Principal Investigator
As of June 19, 2001, WIRB does not require an investigator's signature on the consent form; however, if a consent form is submitted with an investigator signature line, WIRB will not remove it. If an investigator signature line is on the consent form, the investigator or an "equally qualified" sub-investigator must sign the consent form. WIRB does not require that the investigator signature be dated the same as the subject signature.

Why is there a signature block for the person who conducted the consent discussion?

WIRB will automatically include a signature block to be signed by "the person who conducted the informed consent discussion" in compliance with ICH 4.8.8. WIRB does not include a witness signature block unless requested by the site or sponsor.

How do I consent a cognitively impaired subject?

If adult subjects do not have the capacity to consent, WIRB expects that consent will be obtained from a legally authorized representative (LAR), and that the assent of the subject will be obtained to the extent compatible with their capacity.

How is consent obtained from a non-English speaking subject?

WIRB requires that non-English speaking subjects sign a WIRB-approved translated consent form. An ad hoc oral translation of the consent form is not acceptable. WIRB's Translations department can arrange to have a WIRB-approved consent form or subject material translated into any language, or the site/sponsor can submit to WIRB a translated document along with a signed translator certification statement for verification and approval. Specific submission requirements may be obtained from the WIRB Translations department.

You must also explain your plans for 1) conducting the consent discussion in the language understandable to the subject, and for 2) ongoing communication with the subject throughout the research and in case of emergency.

For example, your site might indicate “At least one member of the research team is fluent in the language that will be used for communication, and that research staff member(s) will be available during emergencies,” “The research team has 24-hour access to a translation service with sufficient medical expertise to discuss the research in this study,” or provide another appropriate plan.

Please provide these plans each time you request a translation into a new language for a particular study. Your translation requests may be delayed if you have not already provided an acceptable language-specific and research-specific plan.

My site is in California, but the contents of the California Experimental Subjects’ Bill of Rights don’t apply to my research project. Can I ask WIRB to omit the Bill from my approved consent form?

Yes, WIRB will consider omitting the Bill from your approved consent form. Sites that believe the Bill is not applicable to their research and that desire to see it omitted from their consent form can submit a change in research request. WIRB review fees apply for requests submitted as changes in research.

As of June 1, 2010, the California Experimental Subject's Bill of Rights is not included in the approved consent form. However, consent forms continue to contain a reference to it ("If you agree to be in this study, you will receive a signed and dated copy of this consent form and the Experimental Subject's Bill of Rights for your records"), and it continues to be provided to California sites with the initial review approval documents.
The text of the applicable California law can be found in the California Health and Safety code Section 24174.

What is a waiver of documentation of consent and what criteria must my study meet if I request one?

A waiver of documentation of consent is a waiver of the requirement for a signature on a consent form. The regulations allow the Board to approve this type of waiver if:
The research is minimal risk and involves no procedures for which written consent is usually required; or

The only record linking the subject and the research would be the consent document and the principal risk of the research is the risk of breach of confidentiality.

Subjects enrolling in a study under this type of waiver must be provided with the elements of consent required by the regulations and subjects must consent to participate.

The Board will need to review the information that is provided to subjects to obtain consent to ensure that the required elements of consent are included in the consent discussion. Investigators requesting a waiver of documentation of consent must submit a written statement or script of this information for the Board’s review. A template “Information Sheet” is available on the Download Forms page.

How do I collect data on partners of subjects who become pregnant?

Many protocols now include instructions for investigators to collect data on the outcome of pregnancies that occur in partners of male subjects. WIRB follows 45 CFR 46, which defines research as use of private, identifiable information for research purposes. Becaise investigators would be obtaining private information from the pregnant partner and infant, the partner would be a subject in the research. Investigators must obtain consent from the pregnant partner before any data collection can occur, and WIRB requires a consent form to be submitted for these subjects if a pregnancy occurs.
If plans for obtaining consent from the pregnant partner (or a request for a consent waiver) are not submitted at initial review, the Board may approve the research, but send a letter reminding the investigator and sponsor that pregnant partners and their infants cannot be followed up on until WIRB approves a consent plan for them. Please note that no action is necessary until such time as a pregnancy occurs.

The letter will be accompanied by a sample consent form template that sites and sponsors may choose to use as a starting point for drafting a consent form for the pregnant partner. The template consent form is available on the Download Forms page. The template consent form cannot be used without WIRB approval.

Are we required to obtain the consent of subjects who were originally enrolled as children, but have now reached the age where they can consent for themselves?

Yes. Unless consent has been waived, WIRB requires you to obtain the consent of subjects who reach the age of majority during the research. You may use the current WIRB-approved consent form to obtain their consent, or, if the approved consent form is not appropriate for doing so, you may download the consent addendum and present it, along with the current WIRB approved consent form, to the subject in order to obtain his/her consent.

If you use the addendum below, please remove the statement from it regarding authorization to use and disclose information if the consent form signed by the parent/guardian did not include an authorization section.

You do not have to seek WIRB approval of the generic addendum before using it if you use it without alteration (besides removal of the authorization statement if appropriate as outlined above).

What if the Board didn’t require all subjects be re-consented, but the site would like to re-consent all subjects?

If the site is not required by the Board to re-consent all subjects, the site is still free to do so.

What if I received two changes to the consent form recently and each accompanying Certificate of Approval provided different re-consenting instructions?

The Board expects you to apply the more strict of the two sets of instructions. For example, if the first consent form change included updated risk information and was accompanied by instructions to re-consent all subjects, and the subsequent consent form change was the addition of a new site and the Board directed that the revised consent form only be presented to new subjects, the site is still expected to provide the updated risk information to all subjects using the most current version of the consent form.

What if I disagree with the Board’s re-consent instructions?

If you disagree with the Board’s re-consent instructions, you may PROMPTLY contact WIRB and ask for a reconsideration; however, we advise you not to delay complying with the Board's instructions.

How does WIRB handle the requirement for clinicaltrials.gov text in consent forms?

As of March 7, 2012, consent forms for
certain types of research must include a new element. Federal regulation 21 CFR 50.25(c) states:

“When seeking informed consent for
applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following
statement shall be provided to each clinical trial subject in informed consent
documents and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion in the
clinical trial registry databank under paragraph (j) of section 402 of the
Public Health Service Act. The statement is: "A description of this clinical trial will be available
on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will
not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any time."

Because not
all research reviewed by WIRB will need to have the statement referenced above
in consent forms, we are in the process of updating our initial review
submission forms with the following new question:

If yes, effective
March 7, 2012, the consent form must include the following statement (verbatim)

“A
description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by
U.S. Law. This Web site will not include information that can identify you. At
most, the Web site will include a summary of the results. You can search this
Web site at any time."

When the
question is answered “yes,” WIRB will include the required statement in the
consent form if it is not already there.

If the
question is answered “no”, WIRB will not include the required statement, but
will not remove it when it is in the submitted consent forms.

If you are
not sure how to answer the question, please consult with your sponsor.

Existing
approved consent forms will not be modified to include the statement unless
WIRB receives a request to add it.

What information is required when submitting advertisements to WIRB for review?

The WIRB Change in Research and Subject Recruitment Submission Form (either a "smart form" version or a paper version) should be used to submit recruitment materials for review after initial review of the research. The basic information required includes: investigator name, sponsor name, research protocol number, and the name of the person submitting. Ads must be submitted and approved by WIRB before they are used.

For best results, when submitting subject recruitment materials or other subject materials (diaries, questionnaires, etc.) that have been previously reviewed by WIRB, state in the cover letter which items have been previously reviewed by WIRB. WIRB support staff will provide the Board with information about the previous Board review, and the previous decision of the Board will be taken into account when the additional materials are reviewed.

If some recruitment will be done on a website, submit the recruitment portions of the website for WIRB review; do not submit the portions of the website that are not intended for subject recruitment.

Ads can be submitted via WIRB's online submission tools, by sending email to ClientServices@wirb.com, or via postal mail or fax.

WIRB requires a copy of print ads as they will appear, to allow the Board to review the font size, font style, images, etc.

Advertisements that will be used by some or all participating investigators should be identified as such in the cover letter or submission form. Identifying shared advertisements as such will help ensure consistent review of ad materials for all participating sites.

Ads are approved in one of two ways: "As Submitted" (no changes) or "As Modified." Board-directed changes are indicated on the ad returned with the certificate of approval.
Ads submitted with the protocol and consent form at the time of initial review will be reviewed with the initial approval packet. Approved ad(s) will be listed on the certificate of approval, and show any changes required by WIRB.
WIRB does not routinely apply approval stamps to approved advertisements. The Certificate of Approval listing approval of the ad is documentation of WIRB's review and approval of the advertisement.

Should I do anything differently if I am submitting audio and/or video recordings?

To avoid costly re-work, audio or video recordings should be submitted first as a script. When the script is approved by WIRB, it may then be used to make the final recording. The recording should then be submitted with a copy of the WIRB approved script for final review as a video tape, audio tape, CD, DVD, Windows Media file (.wm), etc. The audio or video ad is not approved for use until the final recording has been reviewed and approved by WIRB. The submitted audio or video recording is kept in the WIRB files; the recording is NOT returned to the site. Please be sure to retain a copy for use.

Can I make changes to an advertisement without resubmitting to WIRB?

Changes made to an advertisement may alter the effect of the advertisement on potential subjects (changes to pictures, font sizes, font types, etc.). WIRB must review anything that could alter the impact of what was previously reviewed, as required in 21 CFR 56.108(a)(4).

See also the Subject Recruitment Materials section of this website for more information about modifications to approved recruitment materials, or contact Client Services via e-mail at ClientServices@wirb.com or call 1-800-562-4789.

What are the benefits of CPU services?

As an independent review panel CPU Services is pleased to provide:

Specialized Review for your clinical research unit

Accelerated Review Cycle Time

Dedicated Point of Contact

Multiple Meetings Per Week

Authenticated Website

US and international CPU reviews

How do I become a CPU Services client?

If you are interested in becoming a CPU Services client, please contact us or call (866) 956-2467. One of our knowledgeable coordinators will assist you throughout the prequalifying process and answer any questions you may have.

What is WIRB’s turnaround time?

Initial CPU review turnaround is 5-7 days, and 1-2 days for changes in research.

What qualifications does my site need?

The following items must be completed prior to submission of research:

The site needs to verify they are a Clinical Pharmacology Unit

A pre-qualifying site visit must be performed

A primary point of contact must be provided

Agreement to use the preapproved CPU Service Consent Form Template

Does CPU Services review more than first-in-human, healthy subject protocols?

Yes, WIRB reviews all types of Clinical Pharmacology Unit research, including Phase 1, bioequivalence/bioavailability, diabetes, oncology, and renal disease research in both healthy and diseased individuals.

Other

For sites

For sponsors and CROs

For review committees

When is IBC review necessary?

The most common triggers for mandatory IBC review include:
1) Funding: If an institution or research sponsor receives NIH funding for any recombinant DNA research, all the institution’s or sponsor’s rDNA research must comply with the NIH Guidelines, which include IBC review. Other federal agencies or private sponsors may require IBC review as a condition of funding.
2) RAC review: Research submitted voluntarily for RAC review must comply with the NIH Guidelines in full.
3) Local policies or regulations: Universities or health systems sometimes require IBC review as part of their employee risk reduction strategy. Local or state government regulations may also require IBC review.

Does IBC Services provide “central IBC” review?

No. Unlike the IRB regulations, a single IBC cannot review for a multi-center trial because the NIH Guidelines require local IBC review. The IBC must be registered for each institution conducting rDNA research. According to the NIH Guidelines, each local IBC must have at least two unaffiliated local members, who represent the interests of the community. Also, the IBC should include at least one member representing the people who actually handle the rDNA product (“laboratory technical staff”).

How long does it take for IBC approval?

For a site we are already working with, the review meeting will typically occur within a few weeks--sometimes less in urgent circumstances. For a new site starting gene transfer research for the first time, it varies according to the readiness of the site in terms of staff training and experience, facilities and equipment, existence of written safety procedures, etc. It generally takes about 8 weeks to conduct a site visit and hold the first meeting of a new IBC. IBC Services has experience finding workable solutions to the common reasons for delay. Also, we can sometimes refer sites with rDNA experience in specific clinical areas.

How can I get started?

Sites: The best first step is to select a point person to contact IBC Services. We can assemble and register your local IBC even before study arrangements are final (see Part A submission form). Then when the research plan is settled, we will help you prepare for successful IBC review (see Part B submission form). Sponsors: Call us early to discuss your needs and timelines. We can help develop SOPs for safe clinical handling of your product, help draft informative and compliant consent forms, and can help identify sites that have proven capabilities in rDNA trials.

Where are the IBC regulations?

The most important source is the NIH Guidelines for Research Involving Recombinant DNA Molecules”. The NIH Guidelines assign responsibilities to the Institution, the Principal Investigator, and the IBC, but not the sponsor, so it’s important to understand your own compliance obligations. State and local jurisdictions may regulate rDNA research or related topics such as disposal of biohazardous waste. Also, some OSHA regulations are particularly relevant to gene transfer research, such as rules about bloodborne pathogens, needlestick prevention, worker protections (immunizations, personal protective equipment), and provisions for occupational health.

The NIH Guidelines do not assign particular responsibilities to sponsors. The premise of the NIH Guidelines is that the researchers are responsible for biological safety, so the PI is the regulatory ‘touch point’ for the NIH. Sponsors are regulated mainly by the FDA.

When can we close a study with IBC?

The NIH allows the local IBC to determine the scope and duration of IBC oversight, so each local IBC will make its own determination about this typically based on the protocol and the biology of the rDNA product. Considerations may include what is known about the time course of delayed adverse events, the characteristics of the vector or the modified DNA, the population under study, the presence of product at the research site, etc. The IBC action does not affect ongoing oversight requirements of the IRB, the FDA, and the NIH.

Why do gene transfer trials have such long follow-up?

In the US, gene transfer is considered experimental, with possible unknown or delayed long-term consequences. Therefore, long-term follow-up (LTFU) generally goes on for much longer than in drug or device studies—perhaps years or life-long. Current FDA guidance calls for the duration of LTFU to relate to risk characteristics of the specific recombinant product.

What if the sponsor goes out of business during the follow-up?

The NIH Guidelines, which establish the system of IBC oversight, do not assign any responsibilities to commercial sponsors, so IBC oversight is not dependent on sponsor participation. Under the NIH Guidelines, the PI may not modify the research without prospective IBC approval. So the PI remains responsible to conduct the protocol as approved by the IBC. This would include the tests or procedures (such as cancer screening or sample collection) included in the long-term follow-up. The best time for contingency planning is before initiating the research.

“Biosafety Level 2" --what does that mean?

A "biosafety level" describes a set of precautions used to guide safe handling infectious agents. Most gene transfer products are handled at BSL2 or even BSL 1 (the lower end of the scale, with BSL4 the highest). Any clinical site that handles body fluids should be able to provide BSL2 containment using routine medical precautions, procedures, and equipment. Compared to BSL1, BSL2 controls offer additional protection to the product, the people handling it, and the environment. The biggest differences are more attention to proper signage, decontamination, transport, and disposal of the gene transfer product. Many (but not all) gene transfer products require the use of a biological safety cabinet (BSC) to prepare the product.

How can we find supplies such as eyewashes, approved disinfectants, etc.?

Check with your usual medical supplies provider. Your IBC roster will include at least one person who should be able to suggest reliable suppliers in your area. Or check with the Scientific Specialists in the IBCS office .

What can a sponsor do to speed local IBC approval?

Site selection makes a big difference. Some prospective sites may lack appropriate space (such as room for a new freezer, or impervious flooring to allow spill clean up), a key piece of equipment (such as a biosafety cabinet or locking freezer), or a capability (such as an on-site pharmacist if required by protocol). Sites with an NIH-registered IBC and gene transfer experience typically have a head start.
Be sure the protocol, investigator brochure, and any special handling instructions are complete, up to date, and consistent with each other. Incomplete or contradictory specifications can create confusion and delay.

What is an IBC, and what does it do?

The IBC (Institutional Biosafety Committee) is a multidisciplinary group supporting the safe handling of biohazardous materials. Members include at least two people representing the local area. IBC oversight is required for human gene transfer research with federal funding. The NIH Office of Biotechnology Activities has a helpful list of questions and answers about IBCs.

How do I become a committee member?

If you are interested in participating on an IBC in your area, please contact us at (360) 252-2850 or ibcs@wirb.com to introduce yourself as a prospective member, and find out what's involved.

How do I review my meeting documents?

We post meeting documents on our secured website. As an IBC Member you will be provided a username and password, as well as any help you need (individual teaching or online video). If you have any difficulties with the website please contact us at (360) 252-2850 or ibcs@wirb.com.

Other

Education

Consultation

Investigator Credentialing

Does WIRB offer customized training?

Yes. WIRB can design a curriculum and delivery method that meets the individual needs of your organization. Please contact WIRB for more information.

Can I get Continuing Education (CE) credits for WIRB training?

WIRB is able to provide credit for physicians, nurses and pharmacists for some of the educational services we provide. Please contact us directly for more information.

Do you offer customized trainings online?

Yes. WIRB can design a course to meet your organization’s specific objectives and we can deliver the training via webinar.

Can you help identify FDA audit issues?

It is important to ensure that your organization is prepared for an inspection by regulatory authorities. WIRB’s experts can help you prepare for an inspection by reviewing your documentation and performing a gap assessment. If we find any problems, we’ll help you develop appropriate corrective action plans. Our training professionals can also provide training for you and your staff if training deficits are noted.

How much are consultations?

The fee for a consultation is based on the time involved and the expertise required of the consultant. WIRB will work with you to provide the services you need for a reasonable fee.

Does WIRB offer customized training?

Yes. WIRB can design a curriculum and delivery method that meets the individual needs of your organization. Please contact WIRB for more information.

Can I obtain continuing education credits for WIRB training?

WIRB is able to provide credit for physicians, nurses, and pharmacists for some of the educational services we provide. Please contact WIRB for more information.

Do you offer customized trainings online?

Yes. WIRB can design a course to meet your organization’s specific objectives, and we can deliver the training via webinar. Please contact WIRB for more information.

Can I obtain access to a webinar that WIRB conducted in the past?

Yes. Past webinars remain available for several months after the presentation was given.

What does WIRB charge to provide on-site training for my organization?

The fees for customized on-site training vary depending upon the number of hours needed for the course, the number of attendees, and whether any continuing education credit will be awarded. Please contact WIRB for more information.

Can WIRB help me identify issues that the FDA might find objectionable during an audit?

Yes. WIRB’s experts can help you prepare for an inspection by regulatory authorities by reviewing your documentation and performing a gap assessment. If we find any problems, we’ll help you develop appropriate corrective action plans. Our training professionals can also provide training for you and your staff if training deficits are noted.

What are the benefits of having WIRB write my consent form?

WIRB's experienced staff can ensure that your consent form and consent process is compliant with US regulations and ICH E-6 GCP and that should be understood by the target subject population for your research. Use of an IRB Professional to write the consent form could result in fewer required revisions as the document is reviewed by various ethical review boards.

How much are consultations?

The fee for a consultation is based on the time involved and the expertise required of the consultant. WIRB will work with you to provide the services you need for a reasonable fee. Please contact WIRB for more information.

I received an FDA Form 483. How can WIRB help me?

WIRB’s professionals can assess the situation and help you develop a corrective action plan and draft a response to the FDA. This response will provide information on any inaccuracies that might be documented in the form.

What kind of regulatory support can WIRB provide for my IRB?

WIRB’s regulatory experts can provide advice before, during, and after your IRB review to ensure all of the required determinations are made and are in compliance with regulations and local law. Following the meeting, WIRB's consultants can ensure the required notifications are made and the record of the review is sufficient and accurate.

My proposed research is very unusual. I am afraid an IRB might not approve it. What can WIRB do?

WIRB has seen a varied assortment of research, and we have worked with investigators around the globe to address regulatory and ethical issues that might prevent the research from moving forward. WIRB’s experts can help you identify ways to address issues in a manner that helps the researchers obtain the necessary approval while preserving the scientific integrity.

Do I have to be a credentialed investigator to obtain approval from WIRB?

No. If an investigator meets WIRBs requirements, he or she can obtain approval regardless of credentialing. However, WIRB believes that there are advantages to becoming credentialed, especially if the investigator doesn’t have the resources to provide training to staff or obtain information on best practices.

Who should become credentialed?

Investigators should become credentialed if they want to take advantages of one or more of the benefits enjoyed by credentialed investigators, including: (1) training; (2) advice on best practices; (3) ease of submission; (4) accelerated review; and (5) listing on website of investigators who have achieved credentialed status.

How much does it cost to become credentialed?

WIRB does not currently charge for credentialing services.

What if issues of noncompliance are discovered during the credentialing process?

We hope that investigators seeking credentialing are compliant. Nevertheless, issues with compliance may be discovered given the heavily regulated nature of research. When such issues are discovered the WIRB representative will work with the site to develop and implement a corrective action plan. Noncompliance will be reported to the Board for consideration, and the Board will need to take appropriate action. Noncompliance may result in a delay in credentialing, but the sites, sponsors, and research subjects will likely benefit when the compliance issue is corrected.

How do I apply for the International Fellows Program?

To apply to our International Fellows Program, send an email to Ckundert@wirb.com. Your email should include a statement that demonstrates your interest in increasing your capacity for ethical review of human subject research. Please also include a brief paragraph about your experience in human subject research.

Does WIRB provide IRB services for research in Canada?

Yes. In 2001, WIRB established a Canadian panel. The composition of the Board meets all of the requirements of the Division 5 regulations. Clinical research submitted to WIRB by Canadian investigators is reviewed by this panel, reviews are conducted in accordance with Health Canada's Division 5, the Tri Council Policy Statement, ICH GCP E6, and U.S. CFR Title 21 Parts 50 and 56 and CFR Title 45 Part 46. The Board meets every two weeks in its office located in Vancouver, BC, and is fully supported by staff at WIRB's headquarters in Olympia, Washington.

What services does WIRB offer internationally?

In addition to IRB review, WIRB also offers CPUS, IBCS, and Education and Consulting services internationally.

Does WIRB work with local ethics committees?

WIRB can act as the sole IRB in countries where regulations allow, or work with a local IRB or other review committee where it is required.

How does WIRB ensure sensitivity to local laws and cultures?

When WIRB reviews research in other countries, it obtains information on local laws and local attitudes. WIRB may solicit the help of investigators and sponsors in collecting this information. WIRB also utilizes Board members from the WIRB International Fellows Program to provide local research context if reviewing research within the Fellows' respective countries.

Other

Before enrolling a child

Before joining a study

Why people join research studies

Risks and benefits of research

Responsibilities and rights

What is an IRB and what does it have to do with research?

Before most research studies can start, they must be approved by a committee, usually called an "institutional review board" or "IRB". IRBs are made up of scientists, doctors, non-scientists, and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate.

What is the difference between medical care and research participation?

When people see their regular doctor for medical care, they are patients. What a doctor does for his or her patient depends on what will be best for the patient. When a person participates in a research study as a subject, the principal investigator must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient.

Do I have to pay for any of the drugs or procedures in a research study?

You or your insurance company may be responsible for some or all of the costs of the tests and procedures that will be done during the study. Sometimes insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs. Insurance companies may also not pay for complications or injuries arising from your participation in research.

Will I be paid to participate in a research study?

Sometimes subjects are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for subjects to come in for the visits and to have procedures performed. Therefore, the payment will often cover costs like parking and babysitting. Research studies for healthy people generally pay more, because these subjects have no medical problem and may have little reason to join the study.

What do I have to do if I join a research study?

As a participant in a research study you will have responsibilities. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study-related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting, and time off work.

Where can I find some information about enrolling my child in research?

We suggest that you review the information available on www.bostonchild.vitalconsent.com. It is an excellent website devoted to research with children and the concerns parents have about allowing

What is an IRB and what does it have to do with research?

Before most research studies can start, they must be approved by a committee, usually called an "institutional review board," or "IRB." IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the consent form for the research to make sure that it is accurate. If it approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you.

What is research?

Research is an organized way to learn more about almost anything. Research is done in many areas, such as engineering, basic science, psychology, and medicine. When research involves people as subjects, it is called human subject research or clinical research. This website focuses on medical research involving human subjects. Medical research is done to learn more about a drug, a medical device, a medical procedure, or a particular condition or behavior. Some of the terms used to refer to medical research are: Research Study, Clinical Research, Research Trial, Clinical Trial or Experimental Study. Whatever it is called, the goal of medical research is to find better ways to treat conditions, improve health or cure diseases for future patients who have a particular health problem. A research study is done to try and answer a question. The question varies from study to study. The research protocol (study plan) clearly states the question to be asked and discusses all of the tests and procedures that will be done during the research study. The U.S. government usually requires that, before a drug or a device can be sold in the U.S., research studies must be done and the results must show that it is relatively safe and effective for its intended use in humans. If you decide to enter a research study, be sure you know what question the research is trying to answer.
More information about research is available on AAHRPP's website. AAHRPP is an organization that accredits high-quality human research protection programs.

What is a sponsor?

Research is planned and initiated by a sponsor. The sponsor may be a government agency like the National Institutes of Health (NIH), a pharmaceutical or device company, a public institution like a University or Medical College, or an individual person.

What is a protocol?

The protocol is the "blueprint" for how the study will be conducted. All the details of the study are described in the protocol. The principal investigator and other research staff must follow the protocol. If the protocol is not followed, the results of the research study may not be useful enough to answer the questions the research is trying to answer.

What is a Principal Investigator (PI)?

The principal investigator is the person responsible for conducting a research project at one or more locations. The principal investigator is usually a medical doctor. Your own physician may be the principal investigator for a research study or the principal investigator could be a physician who only conducts research studies.

What is the difference between medical care and research participation?

The requirement in research to follow a protocol is what makes a research study different from the medical care patients receive from their personal doctor. When people are in research studies they are subjects. When people see their regular doctor for medical care, they are patients. For a patient, the treating doctor uses his or her clinical judgment to do what is best for each patient. A patient may be started on one course of treatment, then switched to another treatment if the doctor determines that the patient is not improving, or is experiencing side effects. What a doctor does for his or her patient depends on what will be best for the patient.
On the other hand, when a person participates in a research study as a subject, the principal investigator must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient. There are several things commonly done in research studies that are not done in regular medical care, such as randomization, blinding, and use of placebo. It is important to know and remember that there is a difference between being a patient and being a research subject.

What is randomization?

In many research studies subjects are assigned to different groups. The subjects in the different groups may receive different doses of drugs, or different drugs, or different devices or other medical procedures. Many times the assignment to a group is made randomly (like drawing a number from a hat). This means that neither the subject nor the investigator chooses which group the subject is placed in. Randomly assigning subjects to groups helps ensure that the results from the study are more accurate.

What is blinding?

Research often uses a technique called "blinding." Blinding can either be single blinding or double blinding. In double blinding, neither the subject nor the investigator knows which drug or procedure the subject will receive. In single blinding, only one person does not know, either the subject or the investigator. Blinding is done to help eliminate the possibility of bias by the investigator and or the subject, and to help the research results be accurate. There are several ways that a study can be blinded. One common way to blind a study is to use a placebo.

What is a placebo?

A placebo looks like a drug but contains no active medicine. In studies that use placebo, all the participants in the research receive drugs that look exactly the same, but all the drugs do not have the same ingredients. Researchers compare the information about subjects receiving the active drug to the information about subjects who receive the placebo. Placebos help ensure that research results are accurate.
Placebos are not just pills. Sometimes placebos are used in device studies or studies of medical procedures. In these cases, the placebo may be a device that doesn't work, or a fake surgery where a cut is made, but no surgery is done.
The consent form will describe whether the study involves a placebo, so you will know if there is a chance that you will get a placebo.

What is a conflict of interest?

Sometimes a principal investigator or sub investigator may have a conflict of interest. Conflicts of interest can take many forms. The most common conflict of interest arises when a doctor who provides you with medical care is also acting as the researcher overseeing your participation in the research study. In this case, there can be a conflict in his or her duty to make medical decisions in your best interest and his or her duty to follow the research protocol.

Another common type of conflict of interest is financial. For example, the principal investigator might own stock in the sponsoring company, be a paid consultant for the sponsoring company, receive speaking fees from the sponsoring company, or be paid by the sponsoring company to conduct the research. The investigator may hold a patent on the drug or device being studied and stand to benefit if the drug or device is approved for general use. You should feel free to ask if either the principal investigator or research staff has a conflict of interest. If the principal investigator or any of the research staff do have a conflict of interest, discuss how they intend to manage that conflict. Only enter the study if you are satisfied with the safeguards that have been put in place to deal with the potential conflict.

Do I have to pay for any of the drugs or procedures in a research study?

You may be expected to pay for some or all of the tests and procedures that will be done during the study. It is different in each study. Sometimes everything is paid for in a research study, and sometimes you or your insurance will be responsible for all of the costs. Also, be aware that sometimes insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs. Insurance companies may also not pay for complications or injuries arising from your participation in research. Find out what you or your insurance will be billed before you agree to be in a research study. You may also want to contact your insurance company, although it is sometimes difficult to get them to tell you what they will pay for.

Will I be paid to participate in a research study?

Sometimes subjects are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for subjects to come in for the extra visits and to have additional procedures performed. Therefore, the payment will often cover costs like parking and babysitting.
Research studies for healthy people generally pay more, as these subjects have no medical problem and may have little other reason to join the study.

What is the consent form?

Before you enter a research study, you will be given a document called a consent form. Read the form carefully. It should tell you what you need to know in order to decide whether or not to enter the study. For example the consent form should tell you:

Why the study is being done,

How long your participation will last

The potential benefits to you

The potential risks to you

The standard medical options for your condition

If there is payment for participation

The plans to deal with research related injuries

Who will receive information about you from the study

Why do people join research studies?

There are many reasons why a person may choose to be in a research study. If you are considering joining a research study, you should think about what your reasons and goals are for joining and discuss them with friends, family, a trusted health care provider and with the principal investigator or other study personnel. Talking with these people should help you determine if your reason(s) for joining the study agrees with what may happen as a result of your participation and the question the research is trying to answer. The following are examples of reasons why people join research studies:

Some healthy people decide to join a study because they want to help in developing a cure for a particular disease.

Some people decide to join a research study because they have a disease or condition and they want to help find a cure.

Some people decide to join because they have a disease or condition that has not responded to any of the medications available to treat the condition.

Some people decide to join because they have a very advanced stage of disease and no treatment option is available.

Some people decide to join because they have a disease or condition and they have had bad reactions to the available treatments and they are looking for something with fewer side effects.

Some people decide to join a study because they want the money that is paid to subjects.

Whatever your reason, you need to know that there can never be any guarantee given to you that the research drug, device or procedure will work for you or will ever work well enough to be approved for general use. A doctor may tell you about a research study because he or she thinks you may meet the requirements for enrolling. Just because a research study is suggested to you does not mean that you have to join it.
More information about deciding whether to participate in a reseach study is available on AAHRPP's website. AAHRPP is an organization that accredits high-quality human research protection programs.

Are there risks in research?

Joining a research study will usually involve risks. Those risks vary from study to study. You should understand what risks are anticipated in the particular study you are considering and remember that there can always be unanticipated risks for research subjects. The risks should be listed in the consent form. Ask research staff to explain any risks that you do not understand.

Will I benefit if I participate in research?

Sometimes the person (subject) who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the subject participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.

What do I have to do if I join a research study?

As a participant in a research study you will have responsibilities too. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting and time off work.

What are my rights as a research subject?

You have several rights as a research subject:

You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.

If you decide to participate, you have the right to quit at any time. Again, there will be no penalty or loss of benefits.

You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.

You have the right to ask questions about the research study.

You have the right to get a copy of the consent form.

You do not waive any of your legal rights by joining a research study or signing a consent form.

Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study.

If you are looking for more resources to learn about research in general, here is a link to AAHRPP's website. AAHRPP is an organization that accredits high-quality human research protection programs.

Who can I contact with questions or concerns?

If you are in a research study reviewed by the Western IRB (WIRB), the consent form includes information about who you can contact.

If you have a medical emergency, please call your local emergency number, such as 911.

For specific questions about the study or to make appointments, please call the study staff listed in the consent form.

You can call a subject representative at WIRB if you have concerns or complaints you would like to talk about with someone who is not working on the study. If you have a study consent form, please have it available during the call. Click here for the WIRB contact page.

You can also call a subject representative at WIRB if you have general questions, concerns, or comments about being in studies, or if you have questions about the rights of people in studies. Click here for the WIRB contact page.

Do you offer healthcare benefits?

Yes, WIRB offers healthcare benefits, begining the first day of the month following your employment.

When am I eligible for Paid Time Off?

You are eligible to utilize Paid Time Off upon completion of 3 months of employment.

When can I participate in your 401K Plan?

You are eligible to participate in our 401K Retirement plan beginning the first day of the month following your date of hire.